search
Back to results

Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI (ATTRACTIVE)

Primary Purpose

Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intrathrombus Thrombolysis During Primary PCI
Aspiration Thrombectomy During Primary PCI
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients presenting with:

    • Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
    • Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
  2. Referred for PPCI
  3. Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia

  4. High thrombus burden:

    • TIMI thrombus grade 3 or 4 after emergency coronary angiography
    • Or TIMI thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows TIMI thrombus grade 5
  5. Informed consent

Exclusion Criteria:

  1. Rescue PCI after systemic thrombolysis
  2. Previous CABG history
  3. Life expectancy<1 year
  4. Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding
  5. Serious hepatic or kidney dysfunction
  6. Pregnancy and lactation
  7. Uncontrolled hypertension (>180/100mmHg)
  8. Previous hemorrhagic stroke or ischemic stroke in past 3 months
  9. Cardiogenic shock or cardio-pulmonary resuscitation
  10. Informed consent cannot be obtained or follow-up cannot be completed

Sites / Locations

  • China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intrathrombus thrombolysis

Aspiration thrombectomy

Arm Description

Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI

Aspiration thrombectomy during PPCI

Outcomes

Primary Outcome Measures

Rate of major adverse cardiovascular events (MACEs)
Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization

Secondary Outcome Measures

Rate of ischemic stroke and transient ischemic attack (TIA)
Rate of ischemic stroke and transient ischemic attack (TIA) at 30 days
Rate of major bleeding evens (BARC type 2, 3 and 5)
Rate of major bleeding evens (BARC type 2, 3 and 5) at 30 days
Rate of key net benefit outcome
cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis, target-vessel revascularization, stroke and major bleeding evens (BARC 2,3 and 5)

Full Information

First Posted
September 8, 2022
Last Updated
September 22, 2022
Sponsor
China-Japan Friendship Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05554588
Brief Title
Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
Acronym
ATTRACTIVE
Official Title
A Randomized Trial of Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients With High Thrombus Burden
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary intervention(PPCI).
Detailed Description
The hypothesis for ATTRACTIVE trial is that the intrathrombus thrombolysis with microcatheter or pierced balloon compared to manual aspiration thrombectomy will reduce the incidence of major adverse cardiovascular events(MACEs), including cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure rehospitalization, stent thrombosis and target-vessel revascularization at 1 year in STEMI patients with HTB undergoing PPCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrathrombus thrombolysis
Arm Type
Active Comparator
Arm Description
Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI
Arm Title
Aspiration thrombectomy
Arm Type
Active Comparator
Arm Description
Aspiration thrombectomy during PPCI
Intervention Type
Procedure
Intervention Name(s)
Intrathrombus Thrombolysis During Primary PCI
Intervention Description
Intrathrombus Thrombolysis During Primary PCI
Intervention Type
Procedure
Intervention Name(s)
Aspiration Thrombectomy During Primary PCI
Intervention Description
Aspiration Thrombectomy During Primary PCI
Primary Outcome Measure Information:
Title
Rate of major adverse cardiovascular events (MACEs)
Description
Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization
Time Frame
up to 180 days
Secondary Outcome Measure Information:
Title
Rate of ischemic stroke and transient ischemic attack (TIA)
Description
Rate of ischemic stroke and transient ischemic attack (TIA) at 30 days
Time Frame
up to 30 days
Title
Rate of major bleeding evens (BARC type 2, 3 and 5)
Description
Rate of major bleeding evens (BARC type 2, 3 and 5) at 30 days
Time Frame
up to 30 days
Title
Rate of key net benefit outcome
Description
cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis, target-vessel revascularization, stroke and major bleeding evens (BARC 2,3 and 5)
Time Frame
up to 1 year
Other Pre-specified Outcome Measures:
Title
Rate of primary outcome at 30 days and 1 year
Description
Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization at 30 days and 1 year
Time Frame
up to 1 year
Title
Rate of individual components of primary outcome
Description
Rate of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization assessed separately at 30 days, 180 days and 1 year
Time Frame
up to 1 year
Title
Rate of all-cause mortality
Description
Rate of all-cause mortality
Time Frame
up to 1 year
Title
Percentage of myocardial blush grade(MBG) of 0 or 1
Description
Percentage of MBG 0 or 1
Time Frame
up to 30 days
Title
Percentage of ST-segment resolution above 70%
Description
Percentage of ST-segment resolution above 70%
Time Frame
up to 30 days
Title
Percentage of TIMI flow grade 3
Description
Percentage of TIMI flow grade 3
Time Frame
up to 30 days
Title
Incidence of side branch occlusion
Description
Incidence of side branch occlusion
Time Frame
up to 30 days
Title
Incidence of distal embolism
Description
Incidence of distal embolism
Time Frame
up to 30 days
Title
Rate of target vessel dissection
Description
Rate of target vessel dissection assessed by coronary angiography
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting with: Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads Referred for PPCI Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia High thrombus burden: TIMI thrombus grade 3 or 4 after emergency coronary angiography Or TIMI thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows TIMI thrombus grade 5 Informed consent Exclusion Criteria: Rescue PCI after systemic thrombolysis Previous CABG history Life expectancy<1 year Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding Serious hepatic or kidney dysfunction Pregnancy and lactation Uncontrolled hypertension (>180/100mmHg) Previous hemorrhagic stroke or ischemic stroke in past 3 months Cardiogenic shock or cardio-pulmonary resuscitation Informed consent cannot be obtained or follow-up cannot be completed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Zhang, Doctor
Phone
+86 15210849352
Email
bjmuzz@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoxue Sheng, Doctor
Phone
+86 15600268925
Email
shengzhaoxue@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingang Zheng, Doctor
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Zhang
Phone
+8615210849352
Email
bjmuzz@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

We'll reach out to this number within 24 hrs